DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 June 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The rejection under 35 U.S.C. 102(a)(1) has been withdrawn in light of the amendment to the claims filed on 8 June 2026.
The interpretation under 35 U.S.C. 112(f) has been withdrawn in light of the amendment to the claims filed on 8 June 2026.
The objection to the specification has been withdrawn in light of the amendment filed on 8 June 2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 18, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (WO 2021/090056 A1; see IDS of 31 January 2025).
With regards to Claim 1, Yu discloses an ultrasonic endoscope system (combined ultrasound and endoscopy systems 100; Yu ¶ [0031])comprising:
a handle section to be gripped by a user (lower multiple-use handle portion 130; see Yu FIG. 2A & ¶ [0036]);
a cannula section that is connected to the handle section and is to be inserted into a subject (cannula 240 attached to lower multiple-use handle portion 130 via upper housing 130; see Yu FIG. 2A & ¶ [0035]), the cannula section having a distal end portion (distal tip 250 houses the ultrasound probe head 252 and imaging & lighting module 270),connecting the bendable portion and the handle section and that has flexibility (the cannula 240 can be made of a slightly bendable material such that the operator can slightly deflect the cannula, for example by 5-20 degrees, by manually pushing or pulling on the cannula shaft);
an optical imaging element (at distal tip 250 is disposed a camera and lighting module 270; see Yu ¶ [0037]) and an ultrasonic transducer array that disposed in the distal end portion of the cannula section (ultrasound probe head 252 with a plurality of transducer elements {i.e. array} clearly illustrated at distal end 250 in Yu FIG. 2A; see also Yu ¶ [0036]);
an endoscope image processor section connected to the hand section via cable and configured to generate an endoscopic image based on an image signal acquired by the optical imaging element (endoscopy optical image processing unit 180 which is clearly illustrated in FIG. 1C as connected via cable 136; see Yu ¶ [0031]);
an ultrasound image processor section that is housed in the handle section (ultrasound processing unit 182 {of FIG. 1C} can be separated from processing system 170 such as ultrasound processing unit 272 in handle 130; see Yu ¶ [0036] & FIG. 2A); and
a monitor configured to display the ultrasound image and the endoscope image (display 150 configured to display both ultrasound images 154 and camera image 156 side-by-side; see Yu ¶ [0031] & FIG. 1B).
It appears that the single-use embodiment of embodiment of FIGS. 1A-6 may be silent to the struck-through limitations above. However, Yu teaches of:
the cannula section (flexible cannula portion 740; see Yu FIG. 7 & ¶ [0047]) having a distal end portion (distal end 750; see Yu FIG. 7 & ¶ [0047]), a bendable portion (flexible cannula portion 740 ; see Yu FIG. 7 & ¶ [0047]) that is connected to a base end side of the distal end portion and is freely bent (a proximal end {i.e. base end side} of the distal end 750 {which houses the ultrasound probe head 752 and imaging & lighting module 770} is clearly illustrated as connected to a segmented portion of the flexible cannula 740 which is clearly illustrated as having a bend {i.e. bendable portion freely bent}; see Yu ¶ [0047]);
an operation member disposed on the handle section, the operation member including angle knobs that are rotationally moved by the user to bend and deform the bendable portion of the cannula section (flexible cables that provide for steering or bending of the cannula 740 in multiple directions is provided by both rotation and steering mechanical controls similar to that of FIGS. 3B-5C {i.e. said figures clearly illustrate rotational knobs to actuate motion}; see Yu ¶ [0047]);
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu to provide at least a bendable portion and a corresponding operation member as detailed directly above. Doing so would aid in the ultrasound probe head 752 being configured to reduce steering and/or rotation range of motion when compared to probe head 252 (see Yu ¶ [0047]).
While modified Yu discloses of compact ultrasound processing unit 272 which can perform less functionality than ultrasound processing unit 182 to reduce cost, Yu does not explicitly disclose that compact ultrasound processing unit 272 performs image generation (see Yu ¶ [0036]). Accordingly, It appears that modified Yu may be silent to an ultrasound image processor section that is housed in the handle section and configured to generate an ultrasound image by performing signal processing on a reception signal output from the ultrasonic transducer array. However, Yu also teaches of an embodiment of FIGS. 8A-8B in which includes a reuseable handheld portion 830 which includes electronics unit 872 {i.e. ultrasound image processor section} to provide some or all of the functionality of ultrasound processing unit 182, i.e. constructing ultrasound image (see ¶ [0040 & 0049]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Yu to provide at least an ultrasound image processor section that is housed in the handle section and configured to generate an ultrasound image by performing signal processing on a reception signal output from the ultrasonic transducer array. Doing so would aid greater processing capabilities are incorporated therein the detachable handle portion 830 (see Yu ¶ [0049]).
Claim 20 recites similar limitations and are rejected under the same rationale as Claim 1.
With regards to Claim 181, modified Yu teaches of
wherein the handle section has a control substrate for controlling the operation member (handle portion 130 includes one or more buttons 212 can be programmed to control LED lighting level (of LEDs at the distal tip 250), capture still images and/or start and stop recording to video images, and capture and/or start and stop recording to ultrasound data and/or ultrasound images; see Yu FIG. 2A & ¶ [0037]; it should be appreciated that the programmed button would be understood by one of ordinary skill in the art as being operatively connected to a circuit board to perform anyone one of the “control[ling]” operations detailed), and
the ultrasound image processor section is mounted on the control substrate (it should be appreciated that one of ordinary skill in the art would understand that in order for the button(s) 212 to be able to control the “capture and/or start and stop recording to ultrasound data and/or ultrasound images” that said buttons would be operatively in communication {i.e. transmission means between button and processor amounts to a control substrate} with said processor 272).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Yu as applied to claim 1 above, and further in view of Tanaka (US PGPUB 20010052721).
With regards to Claim 21, while modified Yu discloses that cannula 240 may be semi-rigid such that it can be made of a slightly bendable material such that the operator can slightly deflect the cannula, for example by 5-20 degrees, by manually pushing or pulling on the cannula shaft (see Yu ¶ [0035]), it appears that modified Yu may be silent to wherein the handle section has a connection metal portion, and the soft portion of the cannula section has a spiral tube in which a metal band-shaped member is helically wound, a base end portion of the spiral tube being attached to the connection metal portion.
However, Tanaka teaches of an a flexible rotation transmission shaft 7 containing a partially coarsely wound coil shaft having a plurality of metal wires (see Yu Abstract). The shaft 7 is connected to a rotation shaft 8 of a operating section 2 {i.e. handle portion}, wherein the rotational shaft 8 is directly connected with a shaft of a rotational motor (see Tanaka FIG. 1 & ¶ [0024]). It should be appreciated that one of ordinary skill in the art would recognize that metal motor shafts {i.e. metal connection portion} are well known in the art for being metal1.
Response to Arguments
Applicant's arguments filed 8 June 2026 have been fully considered but they are not persuasive.
In particular, Applicant contends that Yu does not disclose the newly amended claim limitations. In particular, Applicant argues “Yu is silent about whether the compact ultrasound processing unit 272 performs signal processing on a received signal output from the ultrasound transducer array to generate an ultrasound image, as in amended claim 1” (see pg. 12). While the Office contends that one of ordinary skill in the art would readily recognize that even though the Yu compact ultrasound processing unit 272 is disclosed to have less functionality than its external counterpart ultrasound processing unit 182, one of said functionalities would inherently include image reconstruction. Regardless, Yu teaches of the embodiment of FIG. 8A-8B which includes a re-useable handle portion 830 which includes electronics unit 872 which is capable of performing all of the functions of ultrasound image processing unit 182 which includes image generation (see Yu ¶ [0040 & 0049]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith M. Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH RAYMOND/ Supervisory Patent Examiner, Art Unit 3798
1 See US PGPUB 20080027327 ¶ [0029]
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